Status:
WITHDRAWN
Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections
Lead Sponsor:
Michael Khazzam
Conditions:
Full-thickness Rotator Cuff Tear
Rotator Cuff Tendinitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. In...
Detailed Description
The proposed study is a three arm, double-blinded, prospective randomized controlled clinical trial with follow-up immediately after the injection and at day 2, and weeks 1, 2, 4, 6, and 12. In this s...
Eligibility Criteria
Inclusion
- Age: \> or = 18 years old
- Rotator Cuff Tendinitis
- Atraumatic Full-thickness Rotator Cuff Tear
- Subjects who speak English
- Women who are of non-childbearing potential
Exclusion
- Age: \< 18 years old
- Prior Shoulder Surgery
- Fracture
- Acute Traumatic Rotator Cuff Tear
- Infection
- Uncontrolled Diabetes Mellitus (HbA1c \>8)
- Uncontrolled High Blood Pressure (Hypertension)
- Recent Prior Shoulder Injection in either the Subacromial space Workers Compensation
- History of Peptic Ulcer disease (includes both Gastric and Duodenal Ulcers), Gastrointestinal perforation, Inflammatory Bowel disease (Ulcerative Colitis, Crohn's disease), or any other gastrointestinal pathology
- Tumor Involving the Shoulder Region
- Prior history of gastrointestinal bleeding, allergic reactions, impaired renal function, seizures or cardiac arrhythmias
- Subject unable to provide informed consent
- Subjects who don't speak English
- Patients who are pregnant or lactating at time of screening or are of pregnant bearing age
- Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response.
- Patients taking any anti-platelet agents, warfarin or other anticoagulants, or SSRIs.
- Patients with any bleeding disorders such as coagulopathy, hypercoagulable state, or platelet disorders including thrombocytopenia.
- Patients with cardiac disease such as congestive heart failure, coronary artery disease, or myocardial infarction.
- Patients with severe renal failure. Patients with severe liver impairment or active liver disease.
- Patients with heavy alcohol use; this is defined as consuming 8 or more drinks per week for a woman and 15 or more drinks per week for a man.
- Patients likely to have severe problems maintaining follow-up, including patients diagnosed with severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations. Patients with a known hypersensitivity to bupivacaine or other local anesthetic agent of the amide-type.
- Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs.
- Patients who are currently on probenecid or pentoxifylline as described in the approved label of Ketorolac tromethamine injection.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04895280
Start Date
November 1 2024
End Date
November 1 2028
Last Update
November 15 2024
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390